Summary

Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery.
Open discectomy used to be a widespread procedure for surgical treatment for symptomatic
LDH. Currently, several minimal invasive surgeries have been uesd widely. Percutaneous
lumbar discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and
ozone therapy combined other minimally invasive treatment could improve other minimally
invasive treatment's clinical effectiveness. The effectiveness of which has been proved to
be comparable to conventional open discectomy.

In this study, a single-blind randomized controlled trial will be performed to evaluate the
effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined
with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.

The primary endpoints of the study will be changes in in pain and functional status by the
Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability
Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as
measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include
response evaluation by MacNab response evaluation criteria as measured at pre- and
post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference
in the mean change from baseline between the two groups.

For the first time,the results of this trial will provide scientific evidence as to the
relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical
treatment for symptomatic lumbar disc herniation.